FDA Recall D-1057-2014
Baxter Healthcare Corp. · Deerfield, IL
Class I — life-threatening Terminated 301 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02
Reason for recall
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Recall record
- Recall number
D-1057-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide, Saudi Arabia and Colombia
- Recall initiated
- 2013-11-18
- Classified by FDA Center
- 2014-01-31
- FDA published
- 2014-02-12
- Terminated
- 2014-09-15
- Recalling firm
- Baxter Healthcare Corp.
- Firm location
- Deerfield, IL
Drug identification
- Brand name(s)
- NITROGLYCERIN IN DEXTROSE
- Generic name(s)
- NITROGLYCERIN
- Manufacturer(s)
- Baxter Healthcare Company
- NDC(s)
0338-1047, 0338-1049, 0338-1051- Route(s)
- INTRAVENOUS